Diffuse Large B Cell LymphomaPhase 3NCT05351346
Genotype-guided Treatment in DLBCL
A Phase 3 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- Rituximab, Cyclophosphamide and Doxorubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement)
- Availability of archival or freshly collected tumor tissue before study enrolment
- International Prognostic Index (IPI) score of 2-5 or 1 with bulky disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Life expectancy greater than or equal to (>/=) 6 months
- The patient or his or her legal representative must provide written informed consent prior to any special examination or procedure for the research
Who cannot join
- Previous chemotherapy.
- Previous stem cell transplantation.
- History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
- Patients with central nervous system (CNS) lymphoma
- Primary mediastinal large B-cell lymphoma
Show all 19Show fewer
- Left ventricular ejection fraction<50%
- Laboratory measures meet the following criteria at screening (unless caused by lymphoma):
- Neutrophils<1.5×10^9/L
- Platelets<75×10^9/L (Platelets<50×10^9/L in case of bone marrow involvement)
- ALT or AST is 2 times higher than the upper limits of normal (ULN), AKP and bilirubin are 1.5 times higher than the ULN.
- Creatinine is 1.5 times higher than the ULN.
- HIV-infected patients
- Positive test results for chronic hepatitis B and hepatitis C infection
- Patients with psychiatric disorders or patients who are known or suspected to be unable to fully comply with the study protocol
- Pregnant or lactation
- Require treatment with strong/moderate CYP3A inhibitors or inducers.
- Inability to swallow capsules or presence of diseases that significantly affect gastrointestinal function, such as malabsorption syndrome, post-bariatric surgery, inflammatory bowel disease and complete or incomplete intestinal obstruction
- Other medical conditions determined by the researchers that may affect the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Weili Zhao, M.D. and Ph.D, 13512112076, zhao.weili@yahoo.com
About this study
Official title: A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
CyclophosphamideDrug
Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
DoxorubicinDrug
Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
VincristineDrug
Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
PrednisoneDrug
Prednisone PO will be administered as per the schedule specified in the respective arm.
OrelabrutinibDrug
Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
LenalidomideDrug
Lenalidomide PO will be administered as per the schedule specified in the respective arm.
DecitabineDrug
Decitabine IV infusion will be administered as per the schedule specified in the respective arm.
| Study group | Role | What they receive |
|---|---|---|
| R-CHOP-X | Experimental | Patients in R-CHOP-X group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive orelabrutinib 150 mg/day PO on days 1-21, or lenalidomide 25 mg/day PO on days 2-11, or decitabine 10 mg/m² IV on days -5 to -1 followed by standard R-CHOP of every 21-day cycle. Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Orelabrutinib; Drug: Lenalidomide; Drug: Decitabine |
| R-CHOP | Active comparator | Patients in R-CHOP group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² iv, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for 6 cycles. Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Secondary outcomes (3)
Complete response rate
Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria.
Measured: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Overall survival
Overall survival was defined as the time from the date of randomization to the date of death from any cause.
Measured: Baseline up to data cut-off (up to approximately 2 years)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: From enrollment to study completion, a maximum of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Qilu Hospital of Shandong University, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Second Hospital of Anhui Medical University, Zhongda Hospital, The First Affiliated Hospital of Soochow University, China-Japan Friendship Hospital, Tongji Hospital, Beijing Hospital, The Second Affiliated Hospital of Dalian Medical University, Zhujiang Hospital, The First Affiliated Hospital of Anhui Medical University North District, Hunan Cancer Hospital, Liaoning Cancer Hospital & Institute, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Cancer Hospital Affiliated to Xinjiang Medical University, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Nanchang University, LanZhou University, Central South University, The Affiliated Hospital of Xuzhou Medical University, Yunnan Cancer Hospital, Henan Cancer Hospital, Fujian Medical University Union Hospital, The First Hospital of Jilin University, The First Affiliated Hospital of Anhui Medical University, Gansu Cancer Hospital, The First Affiliated Hospital of University of Science and Technology of China, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Second Affiliated Hospital of Xi'an Jiaotong University, First Affiliated Hospital Xi'an Jiaotong University, RenJi Hospital, Shandong Cancer Hospital and Institute, Affiliated Cancer Hospital of Harbin Medical University, First Affiliated Hospital of Chongqing Medical University, Fudan University, Chinese Academy of Medical Sciences, Affiliated Hospital of Nantong University, The First People's Hospital of Yunnan, Shanxi Province Cancer Hospital, Fifth Affiliated Hospital of Guangzhou Medical University, Beijing Tongren Hospital, First Affiliated Hospital of Harbin Medical University, The Third Affiliated Hospital of Wenzhou Medical University, Harbin Institute of Hematology, The First Affiliated Hospital of Guangzhou Medical University, Affiliated Hospital of Guilin Medical College, Air Force Military Medical University, China, Affiliated Zhongshan Hospital of Dalian University, Yantai Yuhuangding Hospital, The First Affiliated Hospital of Zhengzhou University, Peking University Third Hospital
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351346
- Sponsor's protocol ID
- GUIDANCE-02
- Status last verified
- Mar 2023
- First submitted
- 24 Apr 2022
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT05351346
- Acronym / sponsor ID
- GUIDANCE-02
- Conditions
- Diffuse Large B Cell Lymphoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- West China Hospital, Qilu Hospital of Shandong University, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, The Second Hospital of Anhui Medical University, Zhongda Hospital, The First Affiliated Hospital of Soochow University, China-Japan Friendship Hospital, Tongji Hospital, Beijing Hospital, The Second Affiliated Hospital of Dalian Medical University, Zhujiang Hospital, The First Affiliated Hospital of Anhui Medical University North District, Hunan Cancer Hospital, Liaoning Cancer Hospital & Institute, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Cancer Hospital Affiliated to Xinjiang Medical University, The First Affiliated Hospital of Xiamen University, The First Affiliated Hospital of Nanchang University, LanZhou University, Central South University, The Affiliated Hospital of Xuzhou Medical University, Yunnan Cancer Hospital, Henan Cancer Hospital, Fujian Medical University Union Hospital, The First Hospital of Jilin University, The First Affiliated Hospital of Anhui Medical University, Gansu Cancer Hospital, The First Affiliated Hospital of University of Science and Technology of China, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Second Affiliated Hospital of Xi'an Jiaotong University, First Affiliated Hospital Xi'an Jiaotong University, RenJi Hospital, Shandong Cancer Hospital and Institute, Affiliated Cancer Hospital of Harbin Medical University, First Affiliated Hospital of Chongqing Medical University, Fudan University, Chinese Academy of Medical Sciences, Affiliated Hospital of Nantong University, The First People's Hospital of Yunnan, Shanxi Province Cancer Hospital, Fifth Affiliated Hospital of Guangzhou Medical University, Beijing Tongren Hospital, First Affiliated Hospital of Harbin Medical University, The Third Affiliated Hospital of Wenzhou Medical University, Harbin Institute of Hematology, The First Affiliated Hospital of Guangzhou Medical University, Affiliated Hospital of Guilin Medical College, Air Force Military Medical University, China, Affiliated Zhongshan Hospital of Dalian University, Yantai Yuhuangding Hospital, The First Affiliated Hospital of Zhengzhou University, Peking University Third Hospital
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R-CHOP-X | Experimental | Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: Prednisone, Drug: Orelabrutinib, Drug: Lenalidomide, Drug: DecitabinePatients in R-CHOP-X group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² IV, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for the first cycle. For the remaining 5 cycles, they will receive orelabrutinib 150 mg/day PO on days 1-21, or lenalidomide 25 mg/day PO on days 2-11, or decitabine 10 mg/m² IV on days -5 to -1 followed by standard R-CHOP of every 21-day cycle. |
| R-CHOP | Active comparator | Drug: Rituximab, Drug: Cyclophosphamide, Drug: Doxorubicin, Drug: Vincristine, Drug: PrednisonePatients in R-CHOP group will receive rituximab 375 mg/m² IV on day 1, cyclophosphamide 750 mg/m² IV, doxorubicin 50 mg/m² iv, and vincristine 1.4 mg/m² IV (maximum 2 mg) on day 2, and prednisone 100 mg/day PO on days 2-6 of every 21-day cycle for 6 cycles. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically-confirmed diffuse large B-cell lymphoma (without central nervous system involvement)
- Availability of archival or freshly collected tumor tissue before study enrolment
- International Prognostic Index (IPI) score of 2-5 or 1 with bulky disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Life expectancy greater than or equal to (>/=) 6 months
Key exclusion criteria (19 listed)
- Previous chemotherapy.
- Previous stem cell transplantation.
- History of malignancies except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Uncontrolled cardio- and cerebro-vascular disease, blood clotting disorders, connective tissue diseases, serious infectious diseases and other diseases
- Patients with central nervous system (CNS) lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabRituximab IV infusion will be administered as per the schedule specified in the respective arm. | Drug | R-CHOP, R-CHOP-X |
| CyclophosphamideCyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm. | Drug | R-CHOP, R-CHOP-X |
| DoxorubicinDoxorubicin IV infusion will be administered as per the schedule specified in the respective arm. | Drug | R-CHOP, R-CHOP-X |
| VincristineVincristine IV infusion will be administered as per the schedule specified in the respective arm. | Drug | R-CHOP, R-CHOP-X |
| PrednisonePrednisone PO will be administered as per the schedule specified in the respective arm. | Drug | R-CHOP, R-CHOP-X |
| OrelabrutinibOrelabrutinib PO will be administered as per the schedule specified in the respective arm. | Drug | R-CHOP-X |
| LenalidomideLenalidomide PO will be administered as per the schedule specified in the respective arm. | Drug | R-CHOP-X |
| DecitabineDecitabine IV infusion will be administered as per the schedule specified in the respective arm. | Drug | R-CHOP-X |
Primary outcome
Progression-free survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Progression-free survival was defined as the time from the date of randomization until the date of the first documented day of disease progression or relapse, using 2014 Lugano criteria, or death from any cause, whichever occurred first.
3 secondary outcomes
Complete response rate
Time frame: End of treatment visit (6-8 weeks after last dose on Day 1 of Cycle 6 [Cycle length=21 days]
Overall survival
Time frame: Baseline up to data cut-off (up to approximately 2 years)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: From enrollment to study completion, a maximum of 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rituximab, Cyclophosphamide and Doxorubicin in people with Diffuse Large B Cell Lymphoma, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao (+862164370045 ext. 610707, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Baseline up to data cut-off (up to approximately 2 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2023.